ACTRN12605000413628已完成3 期
Pilot study investigating the safety & efficacy of 96hr duration local anaesthesia (ropivacaine) infused at the incision site for post-operative pain management following right hemicolectomy
TQEH Research Foundation0 个研究点目标入组 10 人开始时间: 2005年9月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated(—)
- 性别
- All
入选标准
- •Able to give informed consent. ASA Score <4 (ie., level 1, 2 or 3). Normal to mildly elevated biochemical indices of renal and/or hepatic functionMental status of the patient should be considered and included only if in the opinion of the surgeon and other attended medical staff, that the patient is capable of giving informed consent and would be capable of complying with the reasonable instructions to allow the study to progressSmokers are admissible, and other drugs/medicines normally taken, other than those specified below. Patient with no previous abdominal surgery.
排除标准
- •Failure to provide written informed consentUnder 18 years of agePregnancy. Clearly pregnant females with bowel cancer would be a complication requiring specific clinical management, and so not appropriate for this pilot studyASA Score >4 (ie., level 4, 5)Moderate to severely elevated indices of renal and/or hepatic function, and patients with dementiaTaking drugs known to influence ropivacaine kinetics (CYP1A2 or CYP3A inhibitor/inducers; fluvoxamine, quinoline antibacterials, conazole antifungals)Taking drugs that may affect pain perception [narcotics (including codeine containing preparations), tricyclic antidepressants, regular non-steroidal use including COX-2 inhibitors, chronic pain killers, anti-epileptic drugs also used in pain therapy)Larger tumor size (>8cm)Previous abdominal surgery, including laparotomyKnown allergy to ropivacaine or fentanyl.
研究者
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